FORMIT XR 750/MG ER TAB 60/ER TAB

Indications

Approved Uses

Type 2 diabetes mellitus: as an adjunct to diet and exercise, used as monotherapy or in combination with other antidiabetic agents (including insulin).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (metformin ER): start 500 mg once daily with the evening meal (some products allow 750 mg once daily); increase by 500 mg about weekly (or every 1-2 weeks) as tolerated; usual effective dose 1500-2000 mg/day; maximum 2000 mg/day for most ER products (some brands allow up to 2500 mg/day-follow local label).

Initial Dose

500 mg orally once daily with the evening meal.

Maintenance Dose

Up to 2000 mg once daily with the evening meal

Maximum Dose

2000 mg/day (extended-release); 2550 mg/day (immediate-release)

Children's Dosage

Safety and effectiveness of the extended-release formulation in pediatric patients have not been established. Immediate-release is approved for children ≥10 years.

Dose Adjustment Notes

Titrate gradually (e.g., in 500 mg increments about weekly or every 1-2 weeks) to reduce GI effects; assess renal function before initiation and at least annually (more often if at risk). Do not initiate if eGFR 30-45 mL/min/1.73 m²; contraindicated if eGFR <30. If eGFR falls <45, reassess benefit/risk and consider dose reduction; discontinue if <30. Temporarily withhold around iodinated contrast in patients with eGFR 30-60, liver disease, alcoholism, heart failure, or when intra-arterial contrast is used; restart after ~48 hours once renal function is stable.

How to Take

Swallow the extended-release tablet whole once daily with the evening meal; do not crush, chew, or split/cut.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, abdominal pain, flatulence, metallic taste, decreased appetite

Safety & Warnings

Contraindications

Contraindications: severe renal impairment (eGFR <30 mL/min/1.73 m²), acute or chronic metabolic acidosis (including diabetic ketoacidosis), and hypersensitivity to metformin; temporarily discontinue around iodinated contrast in at-risk patients per guidance (not a permanent contraindication).

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (higher with renal impairment, hepatic disease, hypoxic states/heart failure, sepsis, dehydration, excessive alcohol, and interacting drugs); assess eGFR before start and periodically; temporarily withhold for iodinated contrast in at-risk patients and around major surgery/acute illness; monitor for vitamin B12 deficiency with long-term therapy; use extra caution in older adults due to renal function decline.

Age Restriction

Pediatric: safety and effectiveness of the extended-release formulation in pediatric patients have not been established. Geriatric: assess renal function before initiation; use with caution in patients ≥80 years.

Drug Interactions

Interaction Severity

MAJOR: Iodinated contrast media in at-risk patients (risk of AKI → lactic acidosis; hold per guidance). MODERATE: Alcohol (especially excessive/acute intake), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide), ranolazine (↑ metformin exposure), cimetidine/other OCT2/MATE inhibitors (↑ metformin levels). MODERATE/CLINICALLY RELEVANT: Drugs that raise glucose (e.g., corticosteroids, thiazide/loop diuretics) may reduce glycemic control.

Food Interaction

Take with food (preferably the evening meal).

Alcohol Interaction

Dangerous

Special Populations

Children

Safety and effectiveness of the extended-release formulation in pediatric patients have not been established. Immediate-release is approved for children ≥10 years.

Kidney Impairment

eGFR ≥60: no adjustment; eGFR 45-59: continue/initiate with monitoring every 3-6 months; eGFR 30-44: do not initiate-if already on, consider dose reduction (commonly max 1000 mg/day) and monitor about every 3 months; eGFR <30: contraindicated.

Storage & Patient Advice

Stopping the Medicine

Can be stopped without tapering, but should not be stopped without prescriber advice because glycemic control may worsen; arrange alternative diabetes management if discontinued.

Overdose

Overdose may cause lactic acidosis; symptoms include severe nausea/vomiting/abdominal pain, malaise, myalgias, dyspnea/hyperventilation, hypothermia, hypotension, bradyarrhythmias, and altered mental status-requires emergency care, drug discontinuation, supportive management, and hemodialysis when severe.

Patient Counseling

Take once daily with the evening meal; swallow ER tablet whole (do not crush/chew/split). GI upset is common initially and often improves; report severe/persistent symptoms. Avoid excessive alcohol. Seek urgent care for possible lactic acidosis symptoms (e.g., unusual muscle pain, trouble breathing, severe weakness, abdominal pain, feeling cold). Inform providers before contrast imaging/surgery; kidney function and HbA1c will be monitored, and vitamin B12 may be checked with long-term use.

Pharmacology

Mechanism of Action

Decreases hepatic glucose production (gluconeogenesis), decreases intestinal glucose absorption, and increases insulin sensitivity/peripheral glucose uptake (AMPK-mediated effects are implicated).

Duration of Effect

Per dose, the extended-release formulation provides glucose-lowering coverage for approximately 24 hours; overall glycemic control is sustained with continued once-daily dosing, with full therapeutic effect typically evident after about 2-4 weeks.

Bioavailability

Approximately 50-60% (metformin overall; ER may have similar or slightly lower extent with slower absorption depending on product/conditions).

Metabolism

Metformin is not metabolized (no hepatic metabolism) and is eliminated unchanged in the urine via renal tubular secretion.

Excretion

Eliminated renally, largely as unchanged drug (majority recovered in urine).

Protein Binding

Negligible (essentially not protein bound).

Product Information

Available Dosage Forms

Extended-release tablet, Immediate-release tablet, Oral solution.

Composition per Dose

Each extended-release tablet: 750 mg metformin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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